A Utah-designed fix for a common heart defect has received approval for use in Europe and other countries. And its creators are hoping to receive an OK for human trials from the U.S. Food and Drug Administration soon.

Salt Lake City-based Coherex Medical announced Wednesday that its FlatStent EF has received CE Mark clearance for use in Europe and elsewhere. It is a new-generation fix that for the first time closes a Patent Foramen Ovale, or PFO, from within the heart defect itself.

"This is the first real new technology in PFO closure in 15 years," said chief medical officer Dr. Randall Jones.

As they followed 90 patients in clinical trials overseas for six months, they documented "good healing" of the defect, Jones said.

A foramen ovale is a tunnel-like opening between the upper heart chambers that helps a fetus breathe in the womb. The tunnel lets blood bypass the lungs — a good thing in the womb that can cause problems outside it. When it fails to close the way it is supposed to at birth, it's called "patent."

As many as 20 percent of adults have a PFO, though many of them will see no ill effects. For others, the result may be dire. PFOs are blamed for a half-million strokes a year and even more migraine headaches.

When people think of hearts and stents, they picture the small rings that keep a blood vessel open. The FlatStent is a different kind of stent, its purpose to adapt to a PFO's unique shape and pull the opening closed. It is made of Ninitol metal and a polyurethane foam sponge that fosters the growth of tissue in and around it, so the device quickly becomes part of the heart and the closure is complete. The device is threaded into place using a catheter in a minimally invasive procedure that is typically done by interventional cardiologists.

Coherex leaders believe the fact that the tunnel is closed from inside will make a difference in terms of complications, compared with older methods, by reducing blood clot formation, damage to the septal wall and more, said chief executive and president Richard J. Linder.

The European clinical trials in Germany, Switzerland and New Zealand also afforded Coherex the opportunity to look at how often the device closed the PFO on the spot, compared with more slowly as healing and integration occurred. Linder and Jones said they saw closure at the time of the implantation procedure 60 percent of the time. They'd heard older devices closed the PFO on the spot between 10 percent and 30 percent of the time.

Coherex officials believe there is a "multibillion dollar annual market" for PFO closure devices.

Coherex is also developing other technologies to tackle different structural heart defects, Linder said.

E-MAIL: lois@desnews.com